Breast Implant Maker Is Accused Of Misleading Telephone Callers

By PHILIP J. HILTS

Published: December 31, 1991

The Food and Drug Administration said yesterday that the leading maker of silicone breast implants had been making false statements on its consumer information telephone line, and it told the company to stop at once or face disciplinary measures.

The accusations, made in a letter to the manufacturer, the Dow Corning Wright Company, involved statements that were being made by its employees on a consumer line it established to provide information about the gel-filled implants. The letter was made public yesterday by the F.D.A.

Callers were being told that there is virtually no hazard in using the implants.

In November, a panel of the F.D.A. found that the company had failed to perform the necessary studies to show whether the silicone implants were safe, and the panel recommended ordering it to conduct a number of detailed studies and to keep a registry of all patients.

The panel recommended that the implants remain on the market until the data were presented. The F.D.A. Commissioner, Dr. David A. Kessler, is to make a final decision on the matter early next month.

The agency is also examining the company's files in the aftermath of recent accusations that the company withheld information from the agency about the safety of the implants.

In its letter, dated Dec. 30, the F.D.A. told Dan M. Hayes, president of Dow Corning Wright, that these false statements were being made by the company's employees over the telephone: *"Scientific data and research show that breast implants are 100 percent safe."

*"After 30 years of study conducted with patients, there have never been health problems with implants or silicone."

*"Breast implants are safe."

The letter also said company employees had told callers that silicone leaked very little from the implants, "less than half a teaspoon" over decades, and that the substance "doesn't go anywhere."

The callers have been told that the implants rupture only 1 percent of the time, and that implants do not cause immune diseases.

The company advertised its special telephone line number in newspapers, promising to give information "based on 30 years of valid scientific reasearch."

F.D.A. officials said the company had no data to support its assertions about the safety of the implants. Data presented to the agency shows that silicone does leak and that it may migrate to the lymph nodes. It also shows that ruptures may occur in 10 percent to 20 percent of implants after a few years in the body and that several doctors have reported cases of arthritis-like auto-immune diseases that they say may be associated with implants.

The agency ordered the company to stop making false or misleading statements by Jan. 2 or face enforcement action.

Officials of the company, part of a joint venture between Dow Chemical Corp. and Corning Inc., did not return telephone calls yesterday.